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New device for intermittent emptying of the bladder in female children and adolescents: A pilot study

Salvador V C Lima1, Fábio O Vilar2, Eugênio S Lustosa3

  • 1Department of Surgery, Center for Health Sciences, Federal University of Pernambuco, UFPE, Brazil.

Journal of Pediatric Urology
|March 4, 2017
PubMed

Insights

A new intraurethral self-retaining device (ISRD) offers a safe and effective alternative for managing urinary incontinence in female children. This device improved quality of life and minimized urethral trauma compared to clean intermittent catheterization (CIC).

Area of Science:

  • Urology
  • Pediatric Urology
  • Medical Devices

Background:

  • Urinary incontinence (UI) presents significant challenges in urology.
  • Clean intermittent catheterization (CIC) is standard but associated with pain, urethral injury, and reduced quality of life.
  • A novel intraurethral self-retaining device (ISRD) was developed as a potential alternative to CIC.

Purpose of the Study:

  • To evaluate the safety and efficacy of the ISRD in female children and adolescents with UI.
  • To assess the ISRD as an alternative to CIC for bladder emptying.
  • To determine the impact of ISRD on patient quality of life.

Main Methods:

  • A prospective clinical pilot study was conducted at a single institution.
  • Participants included female children and adolescents with UI secondary to myelomeningocele already using CIC.
  • Assessments involved visual analogue scales, adverse event reporting, and the King's Health Questionnaire (KHQ) for quality of life.

Main Results:

  • The ISRD demonstrated efficiency and was well-tolerated by 84% of patients.
  • A significant improvement in quality of life was observed in pediatric patients (p<0.0001).
  • The ISRD showed advantages over CIC, including minimized urethral trauma and outpatient management feasibility.

Conclusions:

  • The ISRD is an effective and secure bladder-draining device for pediatric patients with urinary retention and incontinence.
  • The device significantly improved quality of life as measured by the KHQ.
  • The ISRD promotes patient autonomy, enhancing social interaction and school life.
Abstract

Keywords:
Clean intermittent catheterizationNew deviceQuality of lifeUrinary incontinence

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